Skip to content

Aequalis Humeral Nail System

by Tornier

510(k) K082754

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082754 Date27 Jan 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1757-2018 FDA Class II initiated 26 Mar 2018 on shared 510(k) K082754

    Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.

    • Terminated Z-2315-2015 FDA Class II initiated 25 Jun 2015

    Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →